which entity is mandated to provide a report on the status of patient safety to congress each year

by Arvel Johnston 5 min read

Reporting Patient Safety Events - PSNet

31 hours ago  · Recognizing that Patient Safety is a global health priority, the World Health Assembly (WHA) adopted a resolution on Patient Safety which endorsed the establishment of World Patient Safety Day to be observed annually by Member States on 17 September. >> Go To The Portal


PATIENT SAFETY This Patient Safety Chartbook is part of a family of documents and tools that support the National Healthcare Quality and Disparities Reports (QDR). The QDR are annual reports to Congress mandated in the Healthcare Research and Quality Act of 1999 (P.L. 106-129).

Congress vested the authority for implementing the Patient Safety Act with AHRQ by incorporating its provisions into AHRQ's authorizing statute. As the lead Federal agency for patient safety research, AHRQ is an appropriate partner for PSOs and healthcare providers.

Full Answer

What is the Patient Safety Organizations Act?

The purpose of the Act is to encourage providers to work voluntarily with new organizations, known as Patient Safety Organizations (PSOs), to improve patient safety and to reduce the incidence of events that adversely affect patients.

What are the requirements of the patient safety rule?

The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements; and each entity or component organization must comply with several additional regulatory requirements.

How is the Patient Safety Act implemented with AHRQ?

Congress vested the authority for implementing the Patient Safety Act with AHRQ by incorporating its provisions into AHRQ's authorizing statute. As the lead Federal agency for patient safety research, AHRQ is an appropriate partner for PSOs and healthcare providers.

Can health care providers aggregate patient safety event data?

However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily.

What is patient safety event reporting?

What is the Patient Safety and Quality Improvement Act?

What is AHRQ common format?

How is event reporting used in health care?

Why are event reports limited?

Is there a voluntary event reporting system?

See more

About this website

WHO reports patient safety to Congress?

Final Report to Congress To Improve Patient Safety Outlines Strategies To Speed Progress. A final report (PDF, 1.16 MB) on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ.

Which government Agency has a patient safety network?

AHRQ's Patient Safety Network (PSNet) features a collection of the latest news and resources on patient safety, innovations and toolkits, opportunities for free CME and trainings.

What is a federal patient safety organization?

The Patient Safety Organization (PSO) program established federally recognized PSOs to work with health care providers to improve the safety and quality of patient care. The program also creates the first and only comprehensive, nationwide patient safety reporting and learning system in the United States.

What agencies provide regulatory guidance related to safety and quality for patients and staff?

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for Civil Rights (OCR), Department of Health and Human Services (HHS).

What organization is responsible for patient safety?

A Patient Safety Organization (PSO) works with healthcare providers to help them improve patient safety and healthcare quality and encourage a culture of safety.

What organizations are leading the charge for patient safety?

The Agency for Healthcare Research and Quality (AHRQ) is the lead federal agency charged with improving the quality and safety of America's health-care system.

Which organizations deal with safety and health issues related to the healthcare industry?

U.S. Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication Number 2015-115, (October 2021). NIOSH/OSHA/CDC Toolkit.

Which governmental Agency monitors safety practices in the healthcare environment?

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Which healthcare accrediting agencies monitor safety practices in the healthcare environment?

The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the safety and quality of healthcare for all Americans.

Who created patient safety organization?

Joe KianiPatient Safety Movement Foundation The organization was founded in 2012 by Joe Kiani and is based in Irvine, California. Over the last 7 years, PSMF has gathered 4,710 hospitals over 46 countries.

Which U.S. Department oversees the Health Care Quality Improvement Act?

The Agency for Healthcare Research and Quality (AHRQ) is the federal agency charged with implementation of the Act.

Which created patient safety organizations PSOs to collect aggregate and analyze confidential information reported by health care providers?

The Patient Safety and Quality Improvement Act signifies the Federal Government's commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers.

Report a Patient Safety Concern or File a Complaint

This site uses cookies and other tracking technologies to assist with navigation, providing feedback, analyzing your use of our products and services, assisting with our promotional and marketing efforts, and provide content from third parties.

Patient Safety Event Reporting - National Quality Forum

The National Quality Forum (NQF) operates under a three-part mission to improve the quality of American healthcare by: • building consensus on national priorities and goals for performance improvement and working in partnership to achieve them;

NQF: Serious Reportable Events - National Quality Forum

To ensure that all patients are protected from injury while receiving care, NQF has developed and endorsed a set of Serious Reportable Events (SREs). This set is a compilation of serious, largely preventable, and harmful clinical events, designed to help the healthcare field assess, measure, and report performance in providing safe care.

Sentinel Event Policy and Procedures | The Joint Commission

The Joint Commission adopted a formal Sentinel Event Policy in 1996 to help hospitals that experience serious adverse events improve safety and learn from those sentinel events.

When did WHO start working on patient safety?

WHO's work on patient safety began with the launch of the World Alliance for Patient Safety in 2004 and this work has continued to evolve over time. WHO has facilitated improvements in the safety of health care within Member States through establishment of Global Patient Safety Challenges.

What is patient safety?

Patient Safety is a health care discipline that emerged with the evolving complexity in health care systems and the resulting rise of patient harm in health care facilities. It aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care.

What is the WHO patient safety and risk management unit?

The Patient Safety and Risk Management unit at WHO has been instrumental in advancing and shaping the patient safety agenda globally by focusing on driving improvements in some key strategic areas through:

Why is patient safety important?

Patient safety is fundamental to delivering quality essential health services. Indeed, there is a clear consensus that quality health services across the world should be effective, safe and people-centred. In addition, to realize the benefits of quality health care, health services must be timely, equitable, integrated and efficient.

When is World Patient Safety Day?

Recognizing that Patient Safety is a global health priority, the World Health Assembly (WHA) adopted a resolution on Patient Safety which endorsed the establishment of World Patient Safety Day to be observed annually by Member States on 17 September.

Who enforces the Patient Safety Act?

Often referred to as the Patient Safety Act, the provisions of this law dealing with PSOs are administered by the Agency for Healthcare Research and Quality (AHRQ) and the provisions dealing with its confidentiality protections are interpreted and enforced by the Office for Civil Rights (OCR).

What agency is responsible for the Patient Safety Act?

To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) published the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs.

What is PSWP in healthcare?

Any information that is eligible to become PSWP reported to a PSO by a healthcare provider is protected. The definition of PSWP ( Patient Safety Rule Section 3.20) provides important detail on what information is eligible for protection and when those protections apply.

What is a PSO readmission?

The PSO readmissions Web page contains helpful information and tools that can be used by such hospitals, and PSOs that work with those hospitals, to address the causes of unnecessary readmissions. In fact, any hospital can work with a PSO on any patient safety issue of the hospital's choice.

What are uniform federal protections?

The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of healthcare providers in patient safety and quality improvement initiatives , such as fear of legal liability or professional sanctions.

What is the Patient Safety Act?

The Patient Safety Act and Rule provide protections that are designed to allay fears of providers of increased risk of liability if they voluntarily participate in the collection and analysis of patient safety events.

What is the role of OCR?

OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system.

What is the purpose of the Public Health Service Act?

A BILL. To amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1.

What is the purpose of S. 1567?

S. 1567. To amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals , and for other purposes.

What is the most common form of protection for patient safety reporting?

Because of concerns that patient safety reporting data could be used in malpractice litigation, many statutes provide for protection from disclosure through discovery or subpoena.33 The level of protection varies from State to State, but the most common form of protection is to provide only limited access to individual (identified) reports. Other mechanisms include removing identifying information, making reports anonymous, and destroying reports once an investigation is complete.12, 13 Of course, Federal, State, or regulatory bodies may also obtain access to data, and inconsistencies between a statutory data protection provision and a contradictory mandate elsewhere would have to re resolved, either by agreement or through the courts. A March 2000 roundtable discussion, sponsored by the Kaiser Permanente Institute for Health Policy on the recommendations of an IOM report,34 advised that a default reporting strategy include “confidential reporting to a nonregulatory national entity” as the primary vehicle to collect information on adverse events and near misses, and to promote learning. The roundtable concluded that a voluntary reporting system with strong confidentiality protections would provide incentives for reporting and would create an effective basis for patient safety system improvement.

How many sentinel events were reported in 2000?

The JCAHO voluntary reporting system found that, in 5 years (January 1995–March 2000), approximately 550 sentinel events were reported, and an additional 250 were discovered through media reports.36 After New York adopted a mandatory reporting law, reports of AEs increased from 16,939 in 1999 to 24,368 in 2000, and to 28,689 in 2001. However, numbers do not tell a complete story, and these data should be interpreted as an illustration of changes in the culture of adverse event reporting, and not as overall increases in the number of AEs. The existence of a reporting system, especially a mandated one, commonly increases the number of reports, particularly in the initial phase.

How are sanctions and disclosure related?

Sanctions and disclosure are closely related to the mechanisms of investigation and analysis, and to peer review and confidentiality. Three issues are relevant here: whether the identity of reporters is disclosed and whether provisions exist to protect reporters from retaliation; whether there is a structure for notifying patients or relatives that an AE has occurred and of the outcome of the investigation; and whether the results of root cause analyses or other investigations should be made public. NASHP notes that the most frequent use of data from incident or error reports is aggregating data to identify trends; according to the 2003 NASHP study, this is done in 10 mandatory-reporting States, while 9 States administer sanctions and corrective action, and 8 States issue public reports.

What is the IOM report?

The Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System,1 called for radical changes in health care organization and culture, and urged that the problem be addressed at a national level. Two years later, in a follow-up report looking at quality of care, the IOM reiterated this point more forcefully.2 However, despite the generally positive response to these reports, national reform efforts have stalled.3, 4 The IOM reports and concurrent research concur that while the causes of adverse events (AEs) are multifaceted, the search for a solution is compounded by systemic breakdowns in health care planning, organization, and communication.5 The IOM urged adoption of an internal “safety culture” within health care institutions; however, it was not instructive on how this could be accomplished. While there have been scattered Federal efforts at addressing the patient safety dilemma,6 in the absence of a national model, State legislatures have been active in creating structures for reporting of adverse events. (The abbreviation AE will be used throughout the paper to denote “adverse event,” “medical error,” etc., for purposes of a standard terminology.) Credentialing organizations, peer review entities, and quasi-regulatory bodies such as the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) have also offered responses to the IOM report.7 What has emerged is a period of experimentation with internal and external regulatory models, spurred, in significant part, by constant media attention.

Who enforces HIPAA rules?

The HHS Office for Civil Rights enforces HIPAA rules, and all complaints should be reported to that office. HIPAA violations may result in civil monetary or criminal penalties. For more information, visit the Department of Health and Human Services HIPAA website. external icon.

What are the types of entities that are covered by HIPAA?

The following types of individuals and organizations are subject to the Privacy Rule and considered covered entities: 1 Healthcare providers: Every healthcare provider, regardless of size of practice, who electronically transmits health information in connection with certain transactions. These transactions include claims, benefit eligibility inquiries, referral authorization requests, and other transactions for which HHS has established standards under the HIPAA Transactions Rule. 2 Health plans: Entities that provide or pay the cost of medical care. Health plans include health, dental, vision, and prescription drug insurers; health maintenance organizations (HMOs); Medicare, Medicaid, Medicare+Choice, and Medicare supplement insurers; and long-term care insurers (excluding nursing home fixed-indemnity policies). Health plans also include employer-sponsored group health plans, government- and church-sponsored health plans, and multi-employer health plans.#N#Exception: A group health plan with fewer than 50 participants that is administered solely by the employer that established and maintains the plan is not a covered entity. 3 Healthcare clearinghouses: Entities that process nonstandard information they receive from another entity into a standard (i.e., standard format or data content), or vice versa. In most instances, healthcare clearinghouses will receive individually identifiable health information only when they are providing these processing services to a health plan or healthcare provider as a business associate. 4 Business associates: A person or organization (other than a member of a covered entity’s workforce) using or disclosing individually identifiable health information to perform or provide functions, activities, or services for a covered entity. These functions, activities, or services include claims processing, data analysis, utilization review, and billing.

What is the HIPAA Privacy Rule?

The Privacy Rule standards address the use and disclosure of individuals’ health information (known as “protected health information”) by entities subject to the Privacy Rule. These individuals and organizations are called “covered entities.”. The Privacy Rule also contains standards for individuals’ rights to understand ...

What is the HIPAA rule?

HIPAA Security Rule. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. The US Department of Health and Human Services (HHS) issued ...

What are covered entities?

The following types of individuals and organizations are subject to the Privacy Rule and considered covered entities: Healthcare providers: Every healthcare provider, regardless of size of practice, who electronically transmits health information in connection with certain transactions.

Can a covered entity disclose health information without an individual's authorization?

A covered entity is permitted, but not required, to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations: Disclosure to the individual (if the information is required for access or accounting of disclosures, the entity MUST disclose to the individual) ...

Does HIPAA apply to PHI?

The Security Rule does not apply to PHI transmitted orally or in writing. To comply with the HIPAA Security Rule, all covered entities must do the following: Ensure the confidentiality, integrity, and availability of all electronic protected health information.

What is patient safety event reporting?

Patient safety event reporting systems are ubiquito us in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information. Initial reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals. Voluntary event reporting is therefore a passive form of surveillance for near misses or unsafe conditions, in contrast to more active methods of surveillance such as direct observation of providers or chart review using trigger tools. The Patient Safety Primer Detection of Safety Hazards provides a detailed discussion of other methods of identifying errors and latent safety problems.

What is the Patient Safety and Quality Improvement Act?

The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care providers may choose to work with a PSO and specify the scope and volume of patient safety information to share with a PSO. Because health care providers can set limits on the ability of PSOs to use and share their information, this system does not follow the pattern of traditional voluntary reporting systems. However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily. AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events—in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

What is AHRQ common format?

AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events— in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

How is event reporting used in health care?

A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can be a marker of a positive safety culture within an organization, organizations should resist the temptation to encourage event reporting without a concrete plan for following up on reported events. A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.

Why are event reports limited?

The spectrum of reported events is limited, in part due to the fact that physicians generally do not utilize voluntary event reporting systems.

Is there a voluntary event reporting system?

Voluntary event reporting systems need not be confined to a single hospital or organization. The United Kingdom's National Patient Safety Agency maintains the National Reporting and Learning System, a nationwide voluntary event reporting system, and the MEDMARX voluntary medication error reporting system in the U.S.

Background

Characteristics of Incident Reporting Systems

  • An effective event reporting system should have four key attributes: While traditional event reporting systems have been paper based, technological enhancements have allowed the development of Web-based systems and systems that can receive information from electronic medical records. Specialized systems have also been developed for specific settings, such as the Intensive Care Unit Safety Reporting System and systems for reporti…
See more on psnet.ahrq.gov

Limitations of Event Reporting

  • The limitations of voluntary event reporting systems have been well documented. Event reports are subject to selection bias due to their voluntary nature. Compared with medical record review and direct observation, event reports capture only a fraction of events and may not reliably identify serious events. The spectrum of reported events is limited, in part due to the fact that physiciansgenerally do not utilize voluntary event reporting systems…
See more on psnet.ahrq.gov

Using Event Reports to Improve Safety

  • A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can b…
See more on psnet.ahrq.gov

Current Context

  • At the national level, regulations implementing the Patient Safety and Quality Improvement Act became effective on January 19, 2009. The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care prov...
See more on psnet.ahrq.gov